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Articles by Irena Royzman
CMS Proposes to Expand Eligible Medicines for IRA Price Controls-Innovation at Risk
On May 12, the Centers for Medicare & Medicaid Services released draft guidance on implementing the Inflation Reduction Act’s so-called Drug Price Negotiation Program with major implications for the biopharma industry and patients. The IRA allows CMS to set prices for selected medications. CMS’s new guidance widens the drugs subject to IRA’s price controls and asks stakeholders for comments by June 26. Congress specified that only certain “qualifying single source drugs” are subject to the DPNP.
US Inventors Would Be Badly Harmed Under Proposed Patent Rule
A proposed rule from the US Patent and Trademark Office would radically change patent practice in the US. It would ease and expedite the ability for related patents to be stamped out en masse, without considering them on their merits. The proposal calls for an inventor’s rights in one patent—voluntarily related to a different patent in terms of ownership and term—to be extinguished by an invalidity determination for any claim in the other patent.
Law360: Supreme Court Amgen Ruling's Major Effect On Enablement | JD Supra
January 19, 2024 To embed, copy and paste the code into your website or blog: Eight months ago, the U.S. Supreme Court interpreted the enablement requirement in the May 18, 2023, Amgen Inc. v. Sanofi decision.[1] Although the court did not change the law, affirming the U.S. Court of Appeals for the Federal Circuit's approach to enablement, its decision is one of the most impactful for patent enforcement, licensing and prosecution for decades to come across technologies.
Supreme Court Amgen Ruling's Major Effect On Enablement
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High Court Amgen Patent Ruling Promotes Medical Innovation
By Irena Royzman (May 22, 2023, 3:42 PM EDT) -- Last week, in Amgen Inc. v. Sanofi, the U.S. Supreme Court interpreted the patent enablement requirement for the first time in nearly a century.... Stay ahead of the curve In the legal profession, information is the key to success. You have to know what's happening with clients, competitors, practice areas, and industries. Law360 provides the intelligence you need to remain an expert and beat the competition.
SCOTUS Should Reject Attempts to Monopolize a Therapeutic Target
Premium Subscription With this subscription you will receive unlimited access to high quality, online, on-demand premium content from well-respected faculty in the legal industry. This is perfect for attorneys licensed in multiple jurisdictions or for attorneys that have fulfilled their CLE requirement but need to access resourceful information for their practice areas. View Now Team Accounts Our Team Account subscription service is for legal teams of four or more attorneys.
SCOTUS case with implications for attorney-client privilege between CIPOs and C-suite
SCOTUS case with implications for attorney-client privilege between CIPOs and C-suite The recent oral argument in In re Grand Jury suggests the US Supreme Court may broaden confidentiality of communications containing dual-purpose legal and business advice Register to receive our newsletter and gain limited access to subscriber content. Register now Get news, unique commentary, expert analysis and essential resources from the IAM experts. Subscribe now
Why Broad Functional Patent Claims Suppress Medical Innovation Original
By Irena Royzman Jan. 9, 2023, 9:00 AM Kramer Levin’s Irena Royzman analyzes broad functional patent claims of biologic materials and how a current US Supreme Court case could have a major impact on drug development and other areas of innovation. Broad functional patent claims are a hotbed of controversy. These claims to a group of materials are defined by their function, such as binding a biological target, rather than their chemical structure or sequence.
Milk Vitamin Patents Surprisingly Soured By Section 101
United States: Milk Vitamin Patents Surprisingly Soured By Section 101 19 January 2022 by Irena Royzman , Hannah Lee and Shannon P. Gillespie McComb Kramer Levin Naftalis & Frankel LLP Your LinkedIn Connections with the authors To print this article, all you need is to be registered or login on Mondaq.com. On Sept.
Northern District of California Dismisses Challenge to PTAB’s Fintiv Factors | JD Supra
On Nov. 10, 2021, the Northern District of California granted the United States Patent and Trademark Office’s (USPTO) motion to dismiss a lawsuit brought by Apple and co-plaintiffs challenging the Patent Trial and Appeal Board’s (PTAB) use of the Fintiv factors in deciding whether to institute inter partes review (IPR). Apple Inc. et al. v. Andrei Iancu, No. 20-cv-6128-EJD (N.D. Cal.).
ChromaDex Milk Vitamin Formulation Patents Soured by Section 101 | JD Supra
On Sept. 21, 2021, the U.S. District Court for the District of Delaware granted Elysium’s motion for summary judgment that two ChromaDex formulation patents were directed to patent-ineligible subject matter under 35 U.S.C. § 101. ChromaDex, Inc. et al. v. Elysium Health, Inc., Civil Action No. 18-1434-CFC-JLH, 2021 WL 4286527, at *1 (D. Del. Sep. 21, 2021) (ChromaDex). The two ChromaDex patents, U.S. Patent Nos.
United States Calls for Supreme Court to Deny Petition for Certiorari Challenging Fintiv Factors | JD Supra
On Oct. 28, 2021, the Solicitor General filed a brief in opposition to Apple’s petition for a writ of certiorari in Apple Inc. v. Optis Cellular Tech., LLC et al. (No. 21-118). The government argued that the Federal Circuit does not have jurisdiction over appeals of discretionary denials of inter partes review (IPR) pursuant to 35 U.S.C. § 314(d). Apple argues that the Patent Trial and Appeal Board’s Fintiv factors improperly impede IPRs for patents asserted in co-pending district court litigation.
Life sciences patent owners face a transformed inter partes review environment at the USPTO
05 Aug 2021 @IAM_Alerts Ray Millien has left his his job as chief IP officer of Volvo cars to become CEO of @HarnessDickey.
Life sciences patent owners face a transformed inter partes review environment at the USPTO
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The Supreme Court Upholds the Doctrine of Assignor Estoppel While Clarifying Its Scope | JD Supra
On June 29, 2021, the Supreme Court, in Minerva Surgical, Inc. v. Hologic Inc., et al., upheld the doctrine of assignor estoppel, vacated the judgment of the Federal Circuit and remanded for further proceedings consistent with its opinion. The Court’s majority opinion, authored by Justice Kagan, issued from Minerva’s appeal of the Federal Circuit’s application of assignor estoppel.
The Trouble With Functional Antibody Claims | JD Supra
On Feb. 11, 2021, the Federal Circuit issued its decision in Amgen v. Sanofi, affirming the district court’s invalidity ruling for non-enablement of Amgen’s functional antibody claims.
Third-Generation Vaccines Take Center Stage in Battle Against COVID-19 | JD Supra
The biopharmaceutical industry is at the forefront of COVID-19 news due to major advances in vaccine development. Now, more than a year since the first case of COVID-19 and nearing a year since daily life has been upended by the pandemic, hopes for a return to normal rest largely on the effectiveness of mass vaccination against SARS-CoV-2, the virus that causes COVID-19.
Pharma pattern - Intellectual Property Magazine
In the US, the biosimilar statute turned 10 this year and a number of trends have emerged. The litigations under the Biologics Price Competition and Innovation Act (BPCIA) so far have involved nine blockbuster biologic medicines, antibodies and recombinant proteins. For seven of them, biosimilar products are launched. All district court decisions on the merits have been affirmed and most of the litigations have settled.
What's Next For U.S. Biosimilar Litigation
To print this article, all you need is to be registered or login on Mondaq.com. Kramer Levin Naftalis & Frankel LLP attorneys discuss the direction of biosimilar litigation from recent federal court rulings. They also look at trends in patent litigation and what to expect in 2021 and beyond. The Biologics Price Competition and Innovation Act (BPCIA) turned 10 this year, making it a good time to look at recent litigation trends and assess what's ahead for 2021.
Amgen Biosimilar Rows Reveal Manufacturing Patents' Value
Law360 (November 4, 2020, 4:51 PM EST) -- Unlike small chemical drugs, biologic medicines, such as therapeutic proteins and monoclonal antibodies, are typically large molecules with complex structures. Because biologics are made in living cells, the manufacturing processes for biologics are complex.
10 Years Of Biosimilars: Lessons And Trends - Intellectual Property - United States
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Biopharma Develops Antibody and Stem Cell Therapies in the Fight Against COVID-19 | JD Supra
Updated: May 25, 2018: JD Supra is a legal publishing service that connects experts and their content with broader audiences of professionals, journalists and associations.
10 years of biosimilars: lessons and trends
BIOBUSINESS BRIEFS 01 May 2020 doi: 10.1038/d41573-020-00081-5 Competing Financial Interests The authors declare no competing interests. Email address Yes! Sign me up to receive the daily Nature Briefing email. I agree my information will be processed in accordance with the Nature and Springer Nature Limited Privacy Policy.
A Therapeutic Solution for COVID-19: Repurposing Existing Drugs | JD Supra
Updated: May 25, 2018: JD Supra is a legal publishing service that connects experts and their content with broader audiences of professionals, journalists and associations.
BioPharma Develops Needed RNA and Antibody Tests for COVID-19 | JD Supra
Updated: May 25, 2018: JD Supra is a legal publishing service that connects experts and their content with broader audiences of professionals, journalists and associations.
Biopharmaceutical Industry Fights COVID-19 Pandemic with Innovation and Speed | JD Supra
Updated: May 25, 2018: JD Supra is a legal publishing service that connects experts and their content with broader audiences of professionals, journalists and associations.
CAR T-Cell Therapy Takes Off and Brings on Patent Litigation | JD Supra
Updated: May 25, 2018: JD Supra is a legal publishing service that connects experts and their content with broader audiences of professionals, journalists and associations.
The Implications Of USMCA For Biologic Innovation
Law360 (February 11, 2020, 3:04 PM EST) -- On Jan. 29, President Donald Trump signed the United States-Mexico-Canada Agreement into law, which superseded the North American Free Trade Agreement. The USMCA contains a number of key and last-minute revisions that implicate protections for biologic medicines and patent obligations. The first of these revisions concerns market exclusivity for new biologic medicines.
BPCIA Scope Widens: 2020 Spending Bill Moves Chemically Synthesized Polypeptides to Biologic Status | JD Supra
Updated: May 25, 2018: JD Supra is a legal publishing service that connects experts and their content with broader audiences of professionals, journalists and associations.
USMCA: Implications for Biologics and Innovation | JD Supra
Updated: May 25, 2018: JD Supra is a legal publishing service that connects experts and their content with broader audiences of professionals, journalists and associations.
Supreme Court Won’t Take Up Patent Eligibility for Medical Diagnostics | JD Supra
Updated: May 25, 2018: JD Supra is a legal publishing service that connects experts and their content with broader audiences of professionals, journalists and associations.
Biosimilars in 2020: What’s Ahead | JD Supra
Updated: May 25, 2018: JD Supra is a legal publishing service that connects experts and their content with broader audiences of professionals, journalists and associations.
Biosimilar Litigation Trends and Lessons Learned in 2019 | JD Supra
Updated: May 25, 2018: JD Supra is a legal publishing service that connects experts and their content with broader audiences of professionals, journalists and associations.
A Breakthrough Technology is Caught in an Epic Patent Battle
Patent Market Tracker: 2016 Annual Patent TrendsThis report details trends uncovered through patent reassignment data and summarizes the patent transfer activities of the second half of 2015, providing the cleanest, and most timely US patent assignment data available.
Will SCOTUS Provide Guidance on Judicial Review and Claim Construction for IPR Proceedings?
On November 9, 2015, the New York Intellectual Property Law Association filed an amicus brief in support of the petition for a writ of certiorari in Cuozzo Speed Technologies, Inc. v. Lee, No. 15-446. Dorothy Auth, President of the NYIPLA, as well as Eugene Gelernter, Irena Royzman, Jason Vitullo, Charles R. Macedo and David Goldberg were authors on the brief. Charles R.
The Mayo Framework Does Not Moot Preemption
Editorial Note: The following post is taken from the NYIPLA amicus brief filed in Ariosa v. Sequenom. Dorothy Auth, President of the NYIPLA, as well as John Murnane, Irena Royzman, Alicia Russo, and David Ryan, and Erin Austin were authors on the brief. Charles Macedo, Irena Royzman and David Ryan are Co-Chairs of NYIPLA’s Amicus Briefs Committee and Robert Isackson is the NYIPLA Board Liaison.
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